Evaluation of Grief Therapy Approaches for Bereaved Parents
NCT ID: NCT05142605
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
415 participants
INTERVENTIONAL
2022-03-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort 1: Meaning-Centered Grief Therapy (MCGT)
Participants will receive the MCGT intervention for approximately 4 months or longer as needed.
Meaning-Centered Grief Therapy
Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Group 2: Supportive Psychotherapy (SP)
Participants will receive the SP intervention for approximately 4 months or longer as needed.
Supportive Psychotherapy
Supportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Group 3: Enhanced usual care (EUC)
Participants will receive EUC for approximately 4 months or longer as needed.
Enhanced Usual Care
Enhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.
Interventions
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Meaning-Centered Grief Therapy
Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Supportive Psychotherapy
Supportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Enhanced Usual Care
Enhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 or older as indicated by self-report
* Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by self-report
* Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above)
* Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
* English-speaking as per the language assessment items below and willing to receive the intervention in English.
* What is the participant's preferred language?
°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
* How well does the participant speak English?
* Very well (PARTICIPANT IS ELIGIBLE)
* Well (PARTICIPANT is NOT ELIGIBLE)
* Not well (PARTICIPANT is NOT ELIGIBLE)
* Not at all (PARTICIPANT is NOT ELIGIBLE)
* Individuals who are pregnant per self-report are eligible to participate.
* Must be age 18 or over as indicated by self-report
* Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
* Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
* English-speaking as per the language assessment items below and willing to receive the intervention in English
* What is the participant's preferred language?
°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
* How well does the participant speak English?
* Very well (PARTICIPANT IS ELIGIBLE)
* Well (PARTICIPANT is NOT ELIGIBLE)
* Not well (PARTICIPANT is NOT ELIGIBLE)
* Not at all (PARTICIPANT is NOT ELIGIBLE)
* Individuals who are pregnant per self-report are eligible to participate.
* A biological, adoptive, step-parent or legal guardian from across the United States who lost a child diagnosed with cancer as indicated by self-report
* Age 18 or older as indicated by self-report
* Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by self-report
* Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
* English-speaking as per the language assessment items below and willing to receive the intervention in English
* What is the participant's preferred language?
°(Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
* How well does the participant speak English?
* Very well (PARTICIPANT IS ELIGIBLE)
* Well (PARTICIPANT is NOT ELIGIBLE)
* Not well (PARTICIPANT is NOT ELIGIBLE)
* Not at all (PARTICIPANT is NOT ELIGIBLE)
* Individuals who are pregnant per self-report are eligible to participate.
* A biological, adoptive, step-parent, or legal guardian from across the United States as indicated by self-report
* Age 18 or older as indicated by self-report
* Experienced the loss of a child at least 6 months prior to enrollment as indicated by self-report
* Score of 29 or below on the PG-13-R OR lost a child to a cause other than cancer OR child's additional guardian has consented as a Parent Participant and has not provided permission to share participation status
* Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
* English-speaking as per the language assessment items below and willing to receive the intervention in English
* What is the participant's preferred language?
° (Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
* How well does the participant speak English?
* Very well (PARTICIPANT IS ELIGIBLE)
* Well (PARTICIPANT is NOT ELIGIBLE)
* Not well (PARTICIPANT is NOT ELIGIBLE)
* Not at all (PARTICIPANT is NOT ELIGIBLE)
* Individuals who are pregnant per self-report are eligible to participate.
* Must be age 18 or over as indicated by self-report
* Has been identified by the bereaved parent training case participant as a support or someone important to bereaved parent
* Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
* English-speaking as per the language assessment items below and willing to receive the intervention in English
* What is the participant's preferred language?
° (Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
* How well does the participant speak English?
* Very well (PARTICIPANT IS ELIGIBLE)
* Well (PARTICIPANT is NOT ELIGIBLE)
* Not well (PARTICIPANT is NOT ELIGIBLE)
* Not at all (PARTICIPANT is NOT ELIGIBLE)
* Individuals who are pregnant per self-report are eligible to participate.
Exclusion Criteria
* Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
* Prisoners
* Participants unable to consent
* Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
* Inability to access a computer with Internet as indicated by self-report
* Prisoners
* Participants unable to consent
* Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
* Inability to access a computer with Internet as indicated by self-report
* Prisoners
* Participants unable to consent
* Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
* Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
* Prisoners
* Participants unable to consent
* Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
* Inability to access a computer with Internet as indicated by self-report
* Prisoners
* Participants unable to consent
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Miami
OTHER
Responsible Party
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Wendy G. Lichtenthal
Associate Professor, Pending Rank
Principal Investigators
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Wendy G. Lichtenthal, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, United States
St Jude's Children's Hospital (Data collection only)
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Wendy Lichtenthal
Role: primary
Talia Zaider, PhD
Role: primary
Lamia Barakat, PhD
Role: primary
Erica Kaye, MD
Role: primary
Other Identifiers
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20230899
Identifier Type: -
Identifier Source: org_study_id